Valneva SE confirmed that the European Medicines Agency (EMA) has accepted the filing of a marketing authorization application (MAA) for Valneva's inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA's Committee for Human Medicinal Products (CHMP). If the CHMP accepts Valneva's conditional marketing authorization application, the Company confirms it would expect to receive a positive CHMP opinion in June 2022.

If positive opinion is given by the CHMP, the European Commission (EC) will review the recommendation and provide a final decision on the MAA. If granted by the EC, the centralized marketing authorization would be valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.